FDA Device recall Z-1961-2019
Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
- FDA Device
- Class II
- terminated
- Published 2019-07-24
On 2019-07-24 the FDA classified a Class II recall of Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510 by Zimmer Biomet, citing lack of an adequate sterilization validation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1961-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-10 |
| Published | 2019-07-24 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
Comprehensive Reverse Shoulder Instrument Case Total (Outer Case Vault Only), Item Number 595510
Reason
Lack of an adequate sterilization validation.
Identifiers
| code_info | Lots: 251059 254986 203752 260646 263012 264753 2111048 2111052…Lots: 251059 254986 203752 260646 263012 264753 2111048 2111052 2111050 2111051 21110107 21110106 21110117 2291017 2881019 3231032 2981046 3341019 831129 1961120 21110105 21110108 1961120 1961120 1961120 3461146 1961120 1961120 1961120 1961120 1961120 3461146 1081211 1081211 1081211 1951228 1951228 1951228 1951228 1951228 3181203 3181203 3181203 3181203 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1961-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.